DRUG DEVELOPMENT DECONSTRUCTOR MANIFESTO: : “Tell me how you read and I'll tell you who you are.” ― Martin Heidegger
Wednesday, April 30, 2014
Tuesday, April 29, 2014
Targeted failure of the week. Post No 146-147. Custirsen and MultiStem
OncoGenex Pharmaceuticals Inc. (NASDAQ:OGXI) fell $5.85 (60%) to $3.85 on Monday after the company and partner Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) said first-line treatment with IV custirsen (OGX-011) plus docetaxel and prednisone missed the primary endpoint in the Phase III SYNERGY trial to treat metastatic castration-resistant prostate cancer (CRPC). Once-weekly IV custirsen plus docetaxel and prednisone did not improve median overall survival (OS) vs. docetaxel and prednisone alone (23.4 vs. 22.2 months, p=0.207) in the 1,022-patient, open-label trial.
Next half, OncoGenex and Teva plan to complete enrollment of about 630 patients in the Phase III AFFINITY trial of custirsen as second-line treatment of CRPC. Interim data from the Phase III ENSPIRIT trial of the second-generation antisense inhibitor of serum clusterin mRNA as second-line treatment of non-small cell lung cancer (NSCLC) are expected by year end.
From here: http://www.biocentury.com/dailynews/clinical/2014-04-28/oncogenex-falls-on-phase-iii-crpc-miss
Athersys Inc. (NASDAQ:ATHX) fell $1.40 (51%) to $1.33 on Monday after reporting interim data from 88 patients showing a single IV infusion of MultiStem missed the co-primary endpoints in a Phase II trial to treat moderate to severe ulcerative colitis (UC). MultiStem did not improve endoscopic scores from baseline to week eight and did not improve Mayo rectal bleeding subscores from baseline to weeks four and eight vs. placebo. Partner Pfizer Inc. (NYSE:PFE) conducted the double-blind trial, which enrolled patients with moderate to severe active UC despite prior treatment with corticosteroids, immunosuppresants or tumor necrosis factor (TNF) inhibitors. Pfizer has rights to develop and commercialize MultiStem to treat inflammatory bowel disease (IBD), including UC.
MultiStem is also in Phase II testing to treat ischemic stroke and Phase I testing for acute myocardial infarction (MI) and graft-versus-host disease (GvHD). The product comprises allogeneic multipotent adult progenitor cells (MAPC) obtained from the bone marrow of healthy adult donors
From here: http://www.biocentury.com/dailynews/clinical/2014-04-28/athersys-falls-on-multistem-uc-miss
Monday, April 28, 2014
Sunday, April 27, 2014
Saturday, April 26, 2014
Targeted failure of the week. Post No 144-145. Tirasemtiv and CTP-499
Cytokinetics Inc. (NASDAQ:CYTK) fell $8.40 (65%) to $4.59 on Friday after the company said tirasemtiv, its lead unpartnered compound, missed the primary endpoint in the Phase IIb BENEFIT-ALS trial to treat amyotrophic lateral sclerosis (ALS). Twice-daily oral tirasemtiv (formerly CK-2017357) did not improve mean ALS Functional Rating Scale-Revised (ALSFRS-R) total score from baseline to week 12 vs. placebo (p=0.11). Cytokinetics said tirasemtiv "produced mixed results" on secondary endpoints of respiratory function and other measures of skeletal muscle function. The double-blind, international trial enrolled 711 ALS patients. Data are slated to be presented at the American Academy of Neurology meeting next week. From here http://finance.yahoo.com/news/cytokinetics-says-lou-gehrigs-drug-115222740.html and here http://www.biocentury.com/dailynews/topstory/2014-04-25/cytokinetics-plummets-on-tirasemtiv-miss
Concert Pharmaceuticals Inc. (NASDAQ:CNCE) said twice-daily oral CTP-499 missed the primary endpoint of improving urine albumin-to-creatinine ratio (UACR) from baseline to week 24 vs. placebo in a Phase II trial to treat diabetic nephropathy. At week 48, patients treated with CTP-499 had a smaller increase in UACR from baseline compared to placebo (p=0.097), which Concert said may indicate stabilization of UACR in patients treated with CTP-499. The double-blind, U.S. trial enrolled 182 patients with Type II diabetic nephropathy who were receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB). Data were presented at the National Kidney Foundation meeting in Las Vegas.
Concert requested an end-of-Phase II meeting with FDA to discuss the development pathway for CTP-499 and potential Phase III endpoints. CTP-499 is a deuterated analog of an active metabolite of pentoxifylline, a phosphodiesterase-4 (PDE-4) inhibitor.
From here http://www.biocentury.com/dailynews/clinical/2014-04-25/concerts-ctp-499-misses-in-diabetic-nephropathy-trial
Friday, April 25, 2014
Thursday, April 24, 2014
Wednesday, April 23, 2014
Tuesday, April 22, 2014
Monday, April 21, 2014
AZ för sale. $101 B - just not bad...
U.S. pharmaceutical giant Pfizer (PFE.N) has approached British rival AstraZeneca (AZN.L) to propose a 60 billion pound ($101 billion) takeover, Britain's Sunday Times reported.
The paper cited senior investment bankers and industry sources saying that informal conversations about a deal had taken place between the two but that no talks were currently under way after AstraZeneca resisted the approach.
Pfizer and AstraZeneca both declined to comment on the report to Reuters.
AstraZeneca, Britain's second-biggest pharmaceuticals group, has been frequently touted as a potential takeover target as it wrestles with patents expiring on a number of best-selling drugs, leaving future growth uncertain.
From here:
Sunday, April 20, 2014
Saturday, April 19, 2014
Quote of the day
АнекдотПоймал програмист золотую рыбку
"Одно желание?"
Думал-думал...
"Хочу член до земли". И у него оторвало ноги.
Мораль-корректно надо ставить начальные условия задачи.
Friday, April 18, 2014
Pharma's top 10 M&A deals of 2013. The numbers!
All things being relative, 2013 was a pretty good year for M&A in pharma. There were 169 deals valued at $76 billion last year, according to the information ninjas who dice the numbers at EvaluatePharma. That was a 15% jump in the number of deals and a 33% increase in the dollars spent compared to 2012. Analysts had expected as much from 2013, however, because 2012 was the low point for M&A in many years.Read more: Pharma's top 10 M&A deals of 2013 - FiercePharma http://www.fiercepharma.com/special-reports/top-10-ma-deals-2013#ixzz2zDDickJ7
Subscribe at FiercePharma
Thursday, April 17, 2014
Wednesday, April 16, 2014
Monday, April 14, 2014
Saturday, April 12, 2014
Personalised medicinee... A new bubble?
Personalised medicines account for 60% of the over 5,600 active products
currently in the global pharmaceutical industry’s R&D pipeline....Read more at: http://www.pharmatimes.com/Article/14-04-11/UK_at_risk_over_personalised_medicines_report_warns.aspx#ixzz2yeCWB9RH
Friday, April 11, 2014
Targeted failure of the week. Post No 143. Tamiflu.
Flu drug Tamiflu is not as effective as Roche has made it out to be, a Cochrane
Collaboration and BMJ review has concluded.On the positive side, the antiviral was found to shorten symptoms of influenza by half a day and, when used as a preventative treatment, Tamiflu (oseltamivir) reduced the risk of people suffering from flu symptoms.
However, the Cochrane and BMJ review also found “there is no good evidence to support claims that it reduces admissions to hospital or complications of influenza”. In addition, “it is unproven that it can stop people carrying the influenza virus and spreading it to others”.
From here: http://www.pharmatimes.com/Article/14-04-10/Tamiflu_fails_to_support_its_scientific_claims_review_finds.aspx
Thursday, April 10, 2014
Wednesday, April 9, 2014
Targeted failure of the week. Post No 142. Neratinib
Puma Biotechnology Inc. (NYSE:PBYI) fell $6.08 to $80.86 on Tuesday after reporting detailed efficacy and safety data for neratinib (PB272) from the adaptive Phase II I-SPY 2 trial evaluating neoadjuvant breast cancer therapies. Tuesday's move brings to $25.55 (24%) Puma's loss since reporting the data, which translates to a two-day loss in market cap of $770 million for a $2.4 billion valuation.
At the American Association for Cancer Research meeting Puma said that in patients with HER2-positive/hormone receptor-negative breast cancer, oral neratinib plus paclitaxel followed by doxorubicin and cyclophosphamide led to an estimated pathologic complete response (pCR) rate, the primary endpoint, of 55.6% vs. 32.6% for standard therapy consisting of paclitaxel plus Herceptin trastuzumab followed by chemotherapy. The most frequently observed severe adverse event was diarrhea, with grade 3/4 diarrhea in 39% of patients in the neratinib-treated arm vs. 4% in the control arm.
From here: http://www.biocentury.com/dailynews/clinical/2014-04-08/puma-slides-on-detailed-i-spy-2-data
Tuesday, April 8, 2014
Monday, April 7, 2014
Sunday, April 6, 2014
Targeted failure of the week. Post No 141. PEGPH20
Halozyme Therapeutics Inc. (NASDAQ:HALO) fell $3.16 (27%) to $8.43 on Friday after it stopped the Phase II Study 202 evaluating PEGPH20 in combination with Abraxane nab-paclitaxel and gemcitabine to treat untreated pancreatic cancer on the recommendation of an independent DMC. Halozyme halted dosing and enrollment in the open-label trial as "precautionary actions" while the DMC evaluates a possible difference in the thromboembolic event rate between patients treated with PEGPH20 plus Abraxane and gemcitabine and patients treated with Abraxane and gemcitabine alone. Halozyme declined to disclose details, including how many patients have been enrolled in the trial. According to ClinicalTrials.gov, Study 202 is slated to enroll 132 patients.
Halozyme is developing PEGPH20 to improve the absorption and dispersion of IV drugs. The product is a pegylated form of Halozyme's recombinant human PH20 hyaluronidase (rHuPH20), which improves the delivery of subcutaneous drugs.
Saturday, April 5, 2014
Friday, April 4, 2014
Thursday, April 3, 2014
Wednesday, April 2, 2014
Quote of the day regarding having (or not) a PhD
"Oh, yes. I’m very proud of not having a Ph.D. I think the Ph.D. system is an abomination. It was invented as a system for educating German professors in the 19th century, and it works well under those conditions. It’s good for a very small number of people who are going to spend their lives being professors. But it has become now a kind of union card that you have to have in order to have a job, whether it’s being a professor or other things, and it’s quite inappropriate for that. It forces people to waste years and years of their lives sort of pretending to do research for which they’re not at all well-suited. In the end, they have this piece of paper which says they’re qualified, but it really doesn’t mean anything."
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